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Senior Scientist Clinical Pharmacology & Immunology
看过: 133
更新日: 25-04-2024
行业: Staffing Recruiting Biotechnology Research Pharmaceutical Manufacturing
水平: Associate
工作类型: Full-time
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工作内容
Do you have several years of experience in R&D in the biotech/biopharma industry ? Do you want to use your experience for the benefit of a renowned multinational company ? You should then read the following lines!We are looking for a Senior Scientist Clinical Pharmacology & Immunology, for one of our clients specialised in biotechnologies and based in the Vaud canton.
Your Tasks
- Collaborate with clinical development and other relevant stakeholders to define pharmacology and immunology assessments required for the clinical development of a biosimilar project
- Liaise with external consultants (e.g. pharmacologists) to gather required information and expertise
- Collaborate with clinical operations to ensure adequate PK/PD and immunogenicity sample collection, management, handling and shipment
- Provide expertise on data transfer, reconciliation and work with clinical operations and other internal stakeholders during the execution of clinical studies
- Identify and oversee bioanalytical laboratories for PK/PD and immunogenicity sample analysis
- Request, review and manage contracts with bioanalytical laboratories
- Review and comment method development, validation and sample analysis plans and reports in terms of science and regulatory compliance
- Work with project management to align timelines and budget with the overall development plan
- Contribute to bioanalytical laboratory oversight by performing regular visits and summarize outcome in reports
- Coordinate and guide the activities of the bioanalytical laboratories during the execution of clinical studies
- Monitor shipments and track stocks of critical reagents at bioanalytical laboratories
- On bioanalytical and clinical pharmacology and immunology topics, contribute to regulatory submissions and briefing books
- Scientific degree (MS or PhD) in Biochemistry, Chemistry, Immunology or related field
- Minimum 7 years of relevant experience in R&D organization of Biopharma/Biotech Company
- Experience and successful track record with CRO Management for bioanalytics (PK and immunogenicity)
- Good knowledge of GLP and Bioanalytical Guidance documents
- Experience with immunoassays
- Demonstrated success operating in a team environment
- Fluency in English, both oral and written
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最后期限: 09-06-2024
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